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Please carefully read the following information regarding consent, and indicate below whether you agree to participate in this program.

University at Buffalo

Consent to Participate in a Research Study
Title of Protocol: Multiple Sclerosis and Vocational Accommodations
Principal Investigator: Ralph H B Benedict, PhD
Site of Investigation: The Jacobs Neurological Institute; The Buffalo General Hospital

You are being asked to participate in a research study. The purpose of this document is to provide you with information to consider in deciding whether to participate in this research study. Your consent should be made based on your understanding of the nature and risks of the treatment, device, or procedure. Please ask questions if there is anything you do not understand. Your participation is voluntary and will have no effect on the quality of your medical care if you choose not to participate.

PURPOSE OF THE RESEARCH STUDY

Multiple sclerosis (MS) is a disease that can cause/result in a variety of potentially disabling symptoms such as walking impairment, cognitive impairment, difficulty regulating body temperature, and severe fatigue. The debilitating effects on work that some of these disabling symptoms cause can potentially be improved by modifying an employee's work environment or job characteristics. The purpose of this study, which involves research, is to identify job modifications that may prolong employment.

ELIGIBILITY

You are being asked to participate because you are 18 - 70 years of age, have a clinical diagnosis of Multiple Sclerosis (MS), or are matched on demographic variables to an MS sample and you are employed in some capacity. Or, you have previously participated in this research study and have become unemployed/disabled (since you first completed this survey).

PROCEDURES

If you decide to participate in this study, you will be asked to complete this online survey up to 4 times per year, approximately every 3 months. The survey will include questions about your current job status, job accommodations you receive, and a questionnaire about your thinking, learning, and memory. You may also be asked for your feedback on the questions and information in the survey through a focus group or email, this is an entirely optional component of the study and if you choose not to provide feedback you can still participate in the rest of the study.

RISKS / DISCOMFORTS

There are no foreseeable risks, side effects, or discomfort from taking part in this research study.

BENEFITS

There is no direct benefit from participating in this study; however, your participation will provide information that may benefit others with MS.

ALTERNATIVES TO PARTICIPATION IN THE RESEARCH STUDY

Participants may decline to participate.

NEW FINDINGS

You will be told of any new findings developed during the course of the study that may relate to your willingness to continue your participation.

COST ASSOCIATED WITH THE RESEARCH STUDY

You will not be required to pay for any study procedures.

REIMBURSEMENT FOR MEDICAL TREATMENT

Routinely, the Buffalo General Hospital, Erie County Medical Center, Millard Fillmore Hospital, and/or the University at Buffalo, State University of New York, its agents, or its employees do not compensate for or provide free medical care for human subjects/participants in the event that any injury results from participation in a human research project. In the unlikely event that you become ill or injured as a direct result of participating in this study, you may receive medical care, but it will not be free of charge even if the injury is a direct result of your participation.

COMPENSATION FOR SUBJECT PARTICIPATION

There is no compensation associated with this study.

CONFIDENTIALITY/SECURITY

Information related to you will be treated in strict confidence to the extent provided by law. Your identity will be coded and will not be associated with any published results. Your code number and identity will be kept in a password protected file on a private computer of the Principal Investigator, your online responses will be kept on a secure computer hosted by www.vovici.com and the internet communication coded using Secure Socket Layer (SSL) encryption. In order to monitor this research study, representatives from the Health Sciences Institutional Review Board may inspect the research records, which may reveal your identity.

VOLUNTARY PARTICIPATION

Your participation in this study is voluntary (a choice made by you). You may refuse to participate or may discontinue participation at any time during the study without penalty or loss of benefits to which you are otherwise entitled. If you choose to withdraw from the study, no further information will be collected from you or about you. You should know, however, that the information collected about you up to the time of your withdrawal may continue to be used.

SPONSORSHIP

Dr. Ralph Benedict, Principal Investigator, is conducting this research study. This study has no outside sponsorship.

Authorization for the Use and Disclosure of Identifiable Health Information for Research Purposes

You have been asked to be part of a research study under the direction of Dr. Ralph Benedict, the Principal Investigator, and his research team. The study is called Vocational Accommodations and Multiple Sclerosis. The purpose of this study is to collect information on employment changes and job accommodations in people with Multiple Sclerosis.

This authorization form describes information about you and about your health that will be obtained by the researchers when you participate in the research study. Health information is considered "protected health information" when it may directly identify you as an individual. By agreeing to this form you are agreeing to permit the researchers and/or other parties (described in detail below) to have access to this information. If there are any parts of this form that you do not understand, please be sure to ask us for further clarification.

1. What protected health information will be collected as part of this research study?

  • Information from your medical records
  • New health information created from study related tests, procedures, questionnaires as described in the consent.

General description of information: Your personal health information is the information about you that could be used to identify you, such as your name, address, email address, telephone number, date of birth, new and existing medical records, or the types, dates and results of various tests and procedures.

2. Who is authorized to provide or collect this information?

  • KALIEDA Health, Buffalo NY
  • Principal Investigator of designee

3. With whom may your protected health information be shared?
Your health information may be shared with others outside of the research group for purposes directly related to the conduct of this research study or as required by law, including but not limited to:

  • Clinical staff not involved in this research study who may become involved in your care if it is potentially relevant to your treatment.

Your information may also be shared with individuals responsible for general oversight and compliance of research activities. Examples of this include the institution's Privacy and Security Officers or other internal oversight staff, Safety Monitoring Boards, an Institutional Review Board, and accrediting bodies, or with certain government oversight agencies that have authority over the research including the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Office of Human Research Protections (OHRP). Your information may also be shared with other entities as permitted or required by law. All reasonable efforts will be used to protect the confidentiality of your individually identifiable health information that may be shared with others as described above.

All reasonable efforts will be used to protect the confidentiality of your protected health information. There is the potential for individually identifiable information and the associated health information obtained with this authorization to be re-disclosed by the recipient(s). After such a disclosure, the information may no longer be protected by the terms of this authorization against further re-disclosure.

4. How long will this information be kept by the Principal Investigator?

  • This authorization has no expiration date. The researchers may continue to rely on this authorization to obtain and use protected health information about you unless you revoke this authorization in writing.
  • Your protected health information will go into a database that will be maintained indefinitely. Any future study using this information that falls outside the scope of this current study will be required to follow guidelines designed to govern access to that information and to protect the privacy of that information.

5. What are your rights after signing this authorization?

You have the right to revoke this authorization at any time. If you withdraw your authorization, no additional efforts to collect individually identifiable health information about you will be made. You should know, however, that protected health information acquired using this authorization prior to its withdrawal may continue to be used to the extent that the investigator(s) have already relied on your permission to conduct the research. If you chose to withdraw this authorization, you must do so in writing to the following individual:

  • Ralph Benedict, PhD
  • Buffalo General Hospital
  • 100 High Street
  • Buffalo, NY 14203

If you send us a request to withdraw your authorization, we will forward that request to the institutions we have shared it with in order to collect your individually identifiable health information.

6. What will happen if you decide not to sign this authorization?

Refusing to sign this authorization will not affect the present or future care you receive at this institution and will not cause any penalty or loss of benefits to which you are otherwise entitled. If you decide not to sign this authorization, you will not be able to participate in the research study.

ELECTRONIC SIGNATURE:

All of the above has been explained to me and all of my current questions have been answered. I am encouraged to ask questions about any aspects of this research study before signing this document. If, in the future, I have questions, concerns, or complaints about the research, I should contact:

Name: Dr. Ralph Benedict
Title: Principal Investigator
Phone Number: (716) 859-3484

If I have any questions, concerns, or complaints about my rights as a research participant or want to speak to someone who is not associated with the research, I should contact the staff at the Office of the Health Sciences Institutional Review Board, University at Buffalo: (716) 829-2752.

Next
Please complete the following information about yourself.

We will never share or disclose any of your information without your specific consent, or as required by law (as described in the previous consent form).

Contact information
* Case-Sensitive!
Basic information

City State/Province Country
Education

Next
MS Status
Next
Multiple Sclerosis Neuropsychological Questionnaire

Instructions: The following questions ask about problems that you may experience. We want you to rate how often these problems occur AND how severe they are, over the last three months.
*Please respond to all 15 questions!

Very often, very disruptive Quite often, interferes w/life Occasionally, seldom a problem Very rarely, no problem Never, does not occur
  • 4
  • 3
  • 2
  • 1
  • 0

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Next
Fatigue Severity Scale

Instructions: Below are a series of statements regarding your Fatigue. By Fatigue we mean a sense of weariness, lack of energy or total body give-out. It is different from being tired! Please read each statement and choose a number from 1 to 7, where #1 indicates you completely disagree with the statement and #7 indicates you completely agree. Please answer these questions as they apply to the past TWO WEEKS.

Completely
Disagree
Completely
Agree
  • 1
  • 2
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  • 4
  • 5
  • 6
  • 7

  • 1
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  • 7

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  • 7

Next
Current work status

What is your current work status? (please check all that apply)

Disability benefits

Are you receiving disability benefits? (please check all that apply)

Income

$
Work problems
Have you experienced any of the following in the last 3 months due to poor performance or mistakes you made?



Accommodations
Please choose any job accommodations you are currently using/receiving:
 

    Other Accommodations:



Wrap-up